OPUS SPEEDSCREW SYSTEM
FDA 510(k) clearance K101448 · decided 2010-06-21
Clearance details
- K-number
- K101448
- Device name
- OPUS SPEEDSCREW SYSTEM
- Applicant
- Arthrocare Corp.
- Decision
- Substantially Equivalent
- Date received
- 2010-05-24
- Decision date
- 2010-06-21
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- MBI
- Device class
- 2
- Regulation number
- 888.3040
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Sunnyvale, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OPUS SpeedScrew Implant Product Number OM-6500 is a bone anchor Intended to be used for fi recall (Z-0614-2012) | Innovatech Medical Resources L.P. | 2012-01-11 |